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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021273
Company: ORGANON USA INC

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 021273

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOLLISTIM AQ	FOLLITROPIN ALFA/BETA	75 IU/0.5ML	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No
FOLLISTIM AQ	FOLLITROPIN ALFA/BETA	150 IU/0.5ML	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021273

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2005	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021273lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021273ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021273s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2015	SUPPL-11	Supplement		Label is not available on this site.
11/19/2013	SUPPL-9	Supplement		Label is not available on this site.
06/28/2010	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021273s006ltr.pdf
12/24/2008	SUPPL-3	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021273s003ltr.pdf
08/08/2006	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 021273

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2010	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf
08/26/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021273lbl.pdf

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